Arena Pharmaceuticals

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FDA asks Vivus to study diet drug, birth defects

Vivus Inc. said Friday the Food and Drug Administration has asked the drug developer to assess the feasibility of a study on whether an ingredient in the weight-loss drug Qnexa causes birth defects.

The request represents another setback for the drug intended to treat obesity. Vivus and rival Arena Pharmaceuticals Inc. had their diet drugs rejected by the agency in October, as competitor Orexigen Therapeutics Inc.’s weight-loss drug Contrave continued to move through the approval process. Get the full story »

FDA panel rejects diet drug lorcaserin

An advisory panel to the Food and Drug Administration voted against recommending an experimental diet drug known as lorcaserin be approved for marketing.

In a first of several votes to be taken this afternoon, only five members of the panel voted that the drug’s potential benefits to overweight Americans outweigh risks. Nine voted against the drug’s benefits-to-risks ratio. Get the full story »